• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ PLASTIC CONCENTRIC LUER-LOCK SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON, S.A. BD PLASTIPAK¿ PLASTIC CONCENTRIC LUER-LOCK SYRINGE Back to Search Results
Catalog Number 300865
Device Problems Fluid Leak (1250); Explosion (4006)
Patient Problem Exposure to Body Fluids (1745)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd plastipak¿ plastic concentric luer-lock syringe exploded and splattered blood on the patient and the nurse. No serious injury or medical intervention was reported.
 
Manufacturer Narrative
Investigation summary: it has been received 1 picture for investigation. Upon visual inspection of the picture received it can be observed the syringe barrel has resulted broken during use at barrel edge. Dhr of lot 1709222 has been reviewed not finding any annotation or deviation regarding the alleged defect. (b)(4). It has been determined that this incident resulted due to weakness within the barrel edge of the syringe. Recently, a quality project was completed to reduce the occurrence of this defect. Project# (b)(4) has been completed on september 2018 and as part of this project change in mold structure has been performed to strengthen line where barrels resulted broken. This lot was manufactured on september 2017, so actions have been taken after this lot was manufactured.
 
Event Description
It was reported that bd plastipak¿ plastic concentric luer-lock syringe exploded and splattered blood on the patient and the nurse. No serious injury or medical intervention was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD PLASTIPAK¿ PLASTIC CONCENTRIC LUER-LOCK SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8190077
MDR Text Key131481601
Report Number3003152976-2018-00558
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number300865
Device Lot Number1709222
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
-
-